Comparing SingLe- Vs Multi-Fraction Spine STereotActic Radiosurgery in Spinal Metastases

Sponsor: Stanford University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06173401

Patient View

This study evaluates the efficacy of fractionated versus single-fraction SRS in treating spinal metastases. Eligible participants are adults with 1-3 spinal sites needing treatment, spanning 1-2 vertebral levels, and ECOG 0-2. Interventions include single-fraction SRS (22 Gy) and multi-fraction SRS (14 Gy x 2). Participants must consent and adhere to birth control requirements.

Patient Parameters

Program Overview

The goal of this study is to determine whether fractionated Stereotactic radiosurgery (SRS) for spine metastases is associated with improved local tumor control compared to single-fraction SRS. Patients will be randomized to treatment with spine SRS using either 22 Gy in 1 fraction or 28 Gy in 2 fractions.

Eligibility Criteria

Inclusion Criteria

  • Histologically, cytologically, or radiographically confirmed diagnosis of metastatic cancer Age ≥ 18 years
  • Patients who have cervical, thoracic, or lumbar spine metastasis that need treatment.
  • Patients will have 1 to 3 separate spinal sites that require treatment.
  • Each spinal site to be treated on trial will span 1-2 contiguous vertebral levels
  • ECOG 0-2
  • Negative serum or urine pregnancy test within 14 days prior to enrollment for people of childbearing potential or who are not postmenopausal
  • people of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control
  • Ability to understand and the willingness to sign (personally or by a legal authorized representative) the written IRB approved informed consent document

Exclusion Criteria

  • Prior or planned radiation off study within or overlapping with study treatment site
  • Inability to have either an MRI or a CT scan. Patients with pacemaker will be allowed to undergo CT instead of MRI
  • Pediatric patients (age <18 years old), pregnant women, and nursing patients will be excluded
  • Histology's of myeloma or lymphoma
  • Patients with strength 1-3 (of 5), bladder incontinence, bowel incontinence, and/or bladder retention that is associated with spinal site to be treated
  • Prior surgery to spinal site intended to be treated with protocol SRS
  • Excluded those with SINS 13-18

Get This Program In Your Inbox

You can sign up and apply your patients for this program.